A Phase 2/3 interventional study of Tranexamic Acid and Placebo in Shoulder Joint Disease, Complications; Arthroplasty and Intraoperative Complications, sponsored by William Beaumont Hospitals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-19.
Sponsored by William Beaumont Hospitals · Phase 2/3, Interventional, and Treatment
To the Investigators' knowledge, TXA has not been studied in the setting of reverse total shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo in the setting of RTSA. The purpose of this study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates in patients undergoing reverse total shoulder arthroplasty.
Shoulder arthroplasty is a procedure used to relieve pain and dysfunction associated with arthritic destruction of the gleno-humeral joint. It has been demonstrated that in patients with concomitant rotator cuff deficiency, reverse total shoulder arthroplasty (rTSA) is an efficacious procedure that relieves pain as well as increases the lever-arm of the deltoid muscle, thus improving post-operative strength and range of motion.
However, perioperative blood loss in total shoulder arthroplasty can be significant, with an overall rate of allogeneic blood transfusion reported to be 7.4%-43% [1-5]. Patients undergoing reverse total shoulder arthroplasty are at even further risk of requiring a postoperative blood transfusion [2]. Blood transfusions are associated with significant risks to patient health that range from mild to life threatening.
Tranexamic acid (TXA) is an antifibrinolytic medication (reduces the destruction of blood clots, thus promoting the ability to stop bleeding) that is frequently used to reduce perioperative blood loss, blood transfusions and associated costs in major cardiac, vascular, obstetric, and orthopedic procedures. Currently, TXA is increasingly used in orthopedic joint reconstructive surgery and has proven to be safe and effective in reducing blood loss following total knee arthroplasty (TKA) and total hip arthroplasty (THA) [11-33]. Multiple recent meta-analyses have found that use of TXA in the setting of TKA and THA leads to significantly less overall blood loss and lower rates of blood transfusion without increasing rates of venous thromboembolism (VTE) or other complications [34-37]. TXA is now on formulary at William Beaumont Hospital.
100 patients slated to undergo elective reverse total shoulder arthroplasty will be recruited and randomized to receive either an infusion of the standard dose of TXA (10mg/kg) or placebo (an equivalent volume of normal saline) within 60 minutes prior to surgery and at wound closure.
Adult subjects 18 years of age or older will participate in this study after the objectives, methods, and potential hazards of the study have been fully explained, and after they have signed the informed consent form. The Investigator or designee is responsible for keeping a record of all subjects who sign an informed consent form for entry into this study
DATA AND SAFETY MONITORING PLAN Beaumont Research will follow their standard operating policy and procedure for establishing a group of designated Beaumont Hospital faculty that will be responsible for data and safety monitoring. This group will include a clinician, physician, scientific member and statistician. They will meet twice throughout the course of the study. A medical monitor was not appointed since this is a single-site study; Dr. J. Michael Wiater will personally oversee the health and well-being of all patients and submit AE reports, and the designated group will directly review all adverse event reports. Beaumont's Human Investigation Committee will review the data safety monitoring plan as part of their IRB approval process.
Study data will be transcribed by study personnel from the source documents into an electronic database maintained in Excel. The data collections forms are to be completed by the research nurse at the time of the data collection so that they always reflect the latest observations on the subjects participating in the study. Demographic data will be filled in preoperatively, intraoperative blood loss will be recorded in the OR, postoperative blood loss and transfusion will be collected retrospectively, and complications will be recorded as they occur or at 2 and 6 week follow-up. All data entries, corrections and alterations must be made by the investigator or other authorized study personnel. The Research Institute will complete internal auditing at random intervals during the study for data integrity, proper informed consent process implementation and documentation, protocol adherence, and patient safety reporting compliance to regulatory bodies.
Descriptive statistics will be provided for all data collected. Missing data will remain missing and will not be replaced by substitutions or interpolations. Statistical software (SPSS, IBM, Inc) will be used for all analyses. Baseline and demographic data will be compared between the 2 randomization arms to determine if any imbalances exist. Categorical variables will be shown as counts and % frequencies. They will be examined using Pearson's Chi-square where appropriate (expected frequency>5), otherwise a Fisher's Exact test will be used. Continuous variables will be examined for normality. Normally distributed variables will be analyzed using t-tests and non-normally distributed variables will be examined using non-parametric Wilcoxon rank tests. All continuous variables will be shown as means+/- the standard deviation followed by the median and (25th, 75th percentiles) where needed.
The primary outcome of intraoperative and postoperative blood loss and postoperative drop in Hb will be examined for normality. Normally distributed variables will be analyzed using t-tests and non-normally distributed variables will be examined using non-parametric Wilcoxon rank tests. Total number of postoperative transfusions and total number of patients requiring postoperative transfusions will be shown as counts and % frequencies. They will be examined using Pearson's Chi-square where appropriate (expected frequency>5), otherwise a Fisher's Exact test will be used.
The secondary outcomes of systemic and surgical site complications will be examined between the two randomization arms using Pearson's Chi-square where appropriate (expected frequency>5), otherwise a Fisher's Exact test will be used.
712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's enrollment of 116 is above the median of 60 across 470 interventional studies indexed under Joint Diseases.
Browse Joint Diseases studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Preoperative use of anticoagulant therapy within 5 days prior to surgery
Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Drug: Tranexamic Acid
Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Drug: Placebo
Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution.
Also known as: TXA, Antifibrinolytic
Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution.
Also known as: Normal Saline
Total Blood Loss
Total Blood Loss as calculated according to method as described by Good et al. Total Blood Loss (mL) = 1000 X Hb(loss)/Hb(initial)
Time frame: Preoperative through Postoperative Days 1 and 2
Total Hemoglobin Loss
Total hemoglobin loss estimated using the formula for total blood volume described by Nadler et al Hb(loss) = blood volume (L) x \[Hb(initial)(g/L) - Hb(final)(g/L)\] + Hb(transfused)
Time frame: Preoperative through Postoperative Days 1 and 2
Total Drain Output
Total Drain Output as measured postoperatively 0-48 hours
Time frame: 0-48 hours postoperatively
Number of Participants Experiencing Pulmonary Embolism
The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Pulmonary Embolism
Time frame: up to 6-weeks post-operatively
Number of Participants Experiencing Myocardial Infarction
The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Myocardial infarction
Time frame: up to 6-weeks post-operatively
Number of Participants Experiencing Deep Vein Thrombosis
The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Deep venous thrombosis
Time frame: up to 6-weeks post-operatively
Number of Participants Experiencing Hematoma as a Surgical Site Complication
The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Hematoma
Time frame: up to 6-weeks post-operatively
Number of Participants Experiencing Infection as a Surgical Site Complication
The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Infection
Time frame: up to 6-weeks post-operatively
| Milestone | Tranexamic Acid | Normal Saline |
|---|---|---|
| Started | 58 | 58 |
| Completed | 53 | 49 |
| Not completed | 5 | 9 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Screen failures | 4 | 8 |
Total Blood Loss as calculated according to method as described by Good et al. Total Blood Loss (mL) = 1000 X Hb(loss)/Hb(initial)
| Total Blood Loss (mL) | Tranexamic Acid | Normal Saline |
|---|---|---|
| Total Blood Loss | 1122.4 ± 411.6 | 1472 ± 475.4 |
Total hemoglobin loss estimated using the formula for total blood volume described by Nadler et al Hb(loss) = blood volume (L) x \[Hb(initial)(g/L) - Hb(final)(g/L)\] + Hb(transfused)
| g | Tranexamic Acid | Normal Saline |
|---|---|---|
| Total Hemoglobin Loss | 154.6 (138.0 to 171.2) | 200.1 (181.3 to 218.8) |
Total Drain Output as measured postoperatively 0-48 hours
| mL | Tranexamic Acid | Normal Saline |
|---|---|---|
| Total Drain Output | 221 (186 to 256) | 372 (324 to 420) |
The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Pulmonary Embolism
| Participants | Tranexamic Acid | Normal Saline |
|---|---|---|
| Number of Participants Experiencing Pulmonary Embolism | 0 | 0 |
The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Myocardial infarction
| Participants | Tranexamic Acid | Normal Saline |
|---|---|---|
| Number of Participants Experiencing Myocardial Infarction | 0 | 1 |
The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Deep venous thrombosis
| Participants | Tranexamic Acid | Normal Saline |
|---|---|---|
| Number of Participants Experiencing Deep Vein Thrombosis | 0 | 0 |
The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Hematoma
| Participants | Tranexamic Acid | Normal Saline |
|---|---|---|
| Number of Participants Experiencing Hematoma as a Surgical Site Complication | 0 | 0 |
The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment. Infection
| Participants | Tranexamic Acid | Normal Saline |
|---|---|---|
| Number of Participants Experiencing Infection as a Surgical Site Complication | 0 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tranexamic Acid | 0/53 (0%) | 0/53 (0%) | 1/53 (1.9%) |
| Normal Saline | 0/49 (0%) | 1/49 (2%) | 1/49 (2%) |
| Event | Tranexamic Acid | Normal Saline |
|---|---|---|
| Non-ST elevation myocardial infarctionCardiac disorders | 0/53 | 1/49 |
| Event | Tranexamic Acid | Normal Saline |
|---|---|---|
| Skin Allergic ReactionSkin and subcutaneous tissue disorders | 0/53 | 1/49 |
| Syncopal fallGeneral disorders | 1/53 | 0/49 |
| Age, Continuous(years) | Tranexamic Acid | Normal Saline | Total |
|---|---|---|---|
| Mean | 67 ± 9 | 66 ± 9 | 67 ± 9 |
| Sex: Female, Male(Participants) | Tranexamic Acid | Normal Saline | Total |
|---|---|---|---|
| Female | 33 | 27 | 60 |
| Male | 20 | 22 | 42 |
| Region of Enrollment(participants) | Tranexamic Acid | Normal Saline | Total |
|---|---|---|---|
| United States | 53 | 49 | 102 |
Plan to share: No
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